x, 870 p. : 25 cm

Includes bibliographical references and index

Discovery of new medicines / Anand S. Dutta -- Pharmaceutical development / Gavin Halbert -- Preclinical safety testing / David J. Tweats -- Exploratory development / John Posner -- Clinical pharmacokinetics / Paul Rolan and Valeria Molnar -- Purpose and design of clinical trials / Roger A. Yates -- Conduct of clinical trials : good clinical practice / Roger A. Yates -- Medical statistics / Andrew P. Grieve --

Development of medicines : full development / Alan G. Davies and Peter D. Stonier -- The medical department / Darrall L. Higson with revisions by Peter D. Stonier -- Medical marketing / John H. Young -- Information and promotion / D. Michael Humphreys -- The supply of unlicensed medicines for particular patient use / Amanda Wearing and John O'Grady -- Legal and ethical issues relating to medicinal products / Christine H. Bendall, Christopher J.S. Hodges -- The safety of medicines / A. Peter Fletcher and Susan Shaw -- History of drug regulation in the United Kingdom / John P. Griffin and Rashmi R. Shah -- Regulation of human medicinal products in the European Union / Rashmi R. Shah and John P. Griffin --

European regulation of medicinal devices / Christopher J.S. Hodges -- Technical requirements for registration of pharmaceuticals for human use : the ICH process / Dean W.G. Harron -- The regulation of drug products by the United States food and drug administration -- Peter Barton Hutt -- The US FDA in the drug development, evaluation and approval process / Richard N. Spivey, Judith K. Jones, William Wardell and William Vodra -- Past evolution and future prospects of the Pharma Industry and its regulation in the USA / William Wardell, William Vodra, Judith K. Jones and Richard N. Spivey -- Regulatory and clinical trial approval systems in Japan / Yuichi Kubo -- The regulation of therapeutic products in Australia / Janice Hirshorn and Deborah Monk -- Economics of healthcare / Carole Bradley and Jane R. Griffin -- Controls on NHS medicines prescribing and expenditure in the UK (an historical perspective) with some international comparisons / John P. Griffin and Jane R. Griffin

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